Over the last two decades, the Evidence-Based Medicine (EBM) movement has transformed medical science, pushing doctors to rely less on intuition or "common wisdom" in choosing treatments, and more on evidence from studies. Sounds great -- but has EBM become a victim of its own success? This episode features John Ioannidis, Stanford professor of medicine, health and policy, and statistics, and author of the famous paper, "Why Most Published Research Findings are False." John and Julia discuss how EBM has been "hijacked," by whom, and what do do about it.

Reader Comments (7)

Since June 1999 our all-volunteer cancer nonprofit Annie Appleseed Project, has posted the smaller studies in the Holistic world. The fact that BIG PHARMA and our 'science' has moved us to worship Level I studies (many drugs withdrawn, too little attention to adverse effects and NO standards for those issues), does not preclude the simple, natural approaches that rarely if ever get studied that way. It is a closed shop and that is unfortunate.

Over the thousands of years of recorded human existence, many simple herbal and complex herbals (in China and other Eastern nations), have been used and WORKED.

It is simplistic and pseudo-intellectual to only follow the schema designed to approve expensive and always harmful (sometimes helpful) Pharmaceuticals. Constant issue.

This speaker and many others have shown that studies can be less than accurate, outcomes twisted or inappropriate to the patient population, adverse effects ignored, etc. Clinical trials in the current time, are filled with the HEALTHIEST of those with the ailment being tested. The drug gets approved, goes into the open marketplace and can cause harms that were not recorded. This is a constant issue.

Annie Appleseed Project fine print: "Remember: We are NOT Doctors and have NO medical training."Really, not a single doctor on their board of directors.Clinical trials can be "less than accurate," so the "alternative" is a bunch of lousy small biased poorly controlled studies that are exactly the kind that Ioannidis found likely to be wrong and not worth the paper they're written on. It's cancer quackery is what it is.

Reading systematic reviews can be frustrating, when right off the bat they throw away a hundred worthless small studies, and are left with only a handful of randomized controlled trials (RCTs), and those can't really be combined because they use different treatments, placebos, and methodologies. Now, if there are many RCTs, they may show patterns, e.g. RCTs that used higher doses show more effect. If only the resources of the many low-quality studies had been spent on fewer high-quality studies. Quality over quantity. And it would help if they agreed on methodology, like the best randomization techniques and placebos, instead of just winging it.

Sadly, both evidence (and science) can be falsified, which must stem from bad intent, which also sadly, is difficult to prove. The fact that states still license and allow complementary, alternative, holistic, etc., practitioners to set up such 'practices' is problematic. And - it drives other markets of unproven treatments and alleged diagnostics, including in-vitro diagnostics (laboratory tests). The federal government's laboratory regulatory authority under HHS/CMS is CLIA. CLIA objectively states that it does not evaluate clinical validity, deferring to FDA for that critical role. CLIA's certification of "clinical laboratories" who offer unproven tests provides a false credibility to these labs, their tests, and ultimately the CAM practices. Some of these labs also sell proprietary supplements (out of FDA's authority) recommended by the CAM practitioners, driving a market that is essentially protected from federal regulatory oversight.

Quackwatch.org's Dr. Barrett has bees assailed by such laboratories. He is a true unsung hero in the fight for evidence/science-based medicine.

More should be done to educate the public and to address these gaps. And, FDA's proposed framework to regulate laboratory developed tests has been halted due to the result of the (informed...) presidential election outcome.

It probably doesn't need to be said, but the Annie Appleseed Project poster above really doesn't sound like someone you should listen to. Being frustrated by the slow pace of careful science is fine; using that as ammo to turn to "holistic medicine" is a poor idea.

The FDA requires massive research studies far beyond what the European Medicines Agency (EMA) requires for drugs and the EU (CE mark) requires for devices. It takes about 14 years to get drug/device approval in the USA and about 14 months for the same drug/device in Europe. We should have the government conduct independent studies free of conflicts of interest and primarily test new products for safety, affix appropriate warnings, and then let the medical profession evaluate efficacy in valid independent after market trials and anecdotal usage.

The current system of the FDA requiring drug/device manufactures to invest hundreds of millions of dollars into performing their own studies creates an obviously unreliable study results. The drug/device manufactures can only recoup that massive investment by proving efficacy and thereby obtaining approval to market the drug/device.